LAWRENCEVILLE, NJ, 7 March 2016 – Celsion Corporation (NASDAQ: CLSN), a fully-integrated oncology company focused on the development of a portfolio of innovative cancer treatments, today announced the launch of the OPTIMA Study in China. The Company held an Investigators' Meeting for the OPTIMA Study on March 5, 2016 in Shanghai, China. Professor Ronnie T.P. Poon, MD, MBBS, MS, PhD, FRCS (Edin), FACS, Medical Director at the Hong Kong Integrated Oncology Center, Honorary Professor of Surgery at the University of Hong Kong Queen Mary Hospital, and member of the International Liver Cancer Association (ILCA) Governing Board provided the Keynote Address entitled "Treatment Strategies for Early/Intermediate HCC." Professor Poon discussed strategies for treating different stages of primary liver cancer, also known as hepatocellular carcinoma (HCC); including intermediate stage HCC which has been previously thought to be incurable. New treatment strategies, most notably an optimized RFA procedure with the investigational drug, ThermoDox®, show clear promise as a potential cure for intermediate HCC in the years ahead. Investigators and their staff from 20 sites in mainland China and Hong Kong were in attendance. The OPTIMA Study is the Company's global pivotal, double-blind, placebo-controlled trial, evaluating ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin, in combination with radiofrequency ablation standardized to 45 minutes (sRFA) versus sRFA alone to treat newly diagnosed patients with HCC.
"Following a very successful Investigator's startup meeting in Shanghai this past weekend, we are eager to accelerate site initiation and patient enrollment, and expect to complete the process already underway by the end of the second quarter," said Michael H. Tardugno, Celsion's chairman, president and chief executive officer. "Our researchers and principal investigators recognize the importance of the OPTIMA Study to the medical community and its potential to significantly improve overall survival of newly diagnosed HCC patients. With approximately 50% of the 850,000 new cases of primary liver cancer diagnosed each year originating in China, China represents a significant market opportunity and key element of our global development strategy for ThermoDox®."
The Phase III OPTIMA Study is expected to enroll up to 550 patients globally, and has been successfully enrolling patients at 50 clinical sites in 12 different countries in North America, Europe and Asia Pacific. In December 2015, the Company announced that it had received a Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct the ongoing Phase III OPTIMA Study at up to 20 additional clinical sites in China. The Company aims to enroll more than 200 patients in the China territory, the minimum number required by the CFDA to file a New Drug Application (NDA), assuming positive clinical results.

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